Batch disposition code update

Material that is used or manufactured in a GMP site should be dispositioned in accordance with local regulatory requirements. The product disposition must be documented, signed, and dated by the Quality Team representative making the disposition decision.

Disposition code access

To ensure a risk-based approach is followed for the disposition of material, Life Sciences Supply Chain Management introduces a matrix to define users/roles authorized to manually change batch disposition codes, as well as the specific changes allowed.

The Disposition code access form (Inventory management > Setup > Batch > Disposition code access) lets authorized users specify allowed changes to batch disposition codes by security role, with a record for each permitted combination of From and To codes. Users can set the Valid for field to All (if the rule applies to all items) or Material type (if the rule applies only to selected types). If Material type is chosen, clicking the Material type button opens a form to select which material types are allowed for role-specific disposition code changes.

Example

The “QC” role is authorized to modify the batch disposition code from “APP” (Approved) to “REJ” (Rejected). If a user holding any role other than “QC” attempts to change the batch disposition code from “APP” to “REJ”, an error message will be generated.

The “Logistics Supervisor” role is authorized to change the batch disposition code from “QUAR” (Quarantine) to “HOLD” (On Hold), but this permission applies exclusively to consumables. A user in the “Logistics Supervisor” role may change the disposition code from “QUAR” to “HOLD” only for batches linked to items classified as “Consumables”. Otherwise, an error message will be displayed.

Electronic signature for batch disposition code update

In compliance with 21 CFR Annex 11, Life Sciences Supply Chain Management introduces the possibility of securing changes to the batch disposition code with an electronic signature. Only authorized users can modify the disposition code by entering a valid password. The “Reset batch disposition code” electronic signature can be enabled in the Electronic signature requirements form (Organization administration > Setup > Electronic signatures > Electronic signature requirements).

Batch disposition history

Life Sciences Supply Chain Management logs all changes to the disposition code of a batch in the Batch disposition history form, accessible by clicking Inquiries > Batch disposition history from the Batches form (Inventory management > Inquiries and reports > Batches). The system records the following information:

Batch number – batch whose disposition code was modified.
Old batch disposition code.
New batch disposition code.
Created by – user who modified the batch disposition code.
Created date and time – Date and time of the modification.
Use code – Use code of the batch at the time of the disposition code change.

Update batch disposition status batch job

Microsoft Dynamics 365 Finance & Supply Chain Management allows for the definition of the Update batch disposition status job for the automatic update of batch disposition codes based on predefined conditions (Inventory management > Periodic tasks > Batches > Update batch disposition status). Authorized users can define the batch disposition code to be assigned and the conditions when it should be assigned to batches. For example, the Expired batch disposition code can be automatically assigned to all batches that have reached their expiration date.

Life Sciences Supply Chain Management allows using the Update batch disposition status batch job to automatically update the batch disposition codes even when the Reset batch disposition code electronic signature is enabled. While users must process the electronic signature when manually changing the disposition code, the signature is not required when the modification is done automatically via the batch job.